Data and Safety Monitoring Boards and Data Safety Monitoring Plans Register
Date:
Tuesday, January 21, 2025
Time:
10:30 am to 11:30 am
Location:

Virtual

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About This Event

Presented by IRBMED, a unit of the Medical School Office of Research, this course will review when studies are required to have a DSMP or DSMB and how to develop an appropriate DSMP. A DSMB is an independent group that advises the study team regarding subject safety, study conduct, and efficacy. The DSMB will also make recommendations concerning the continuation, modification, or termination of the trial. A DSMP outlines how subject safety and data integrity will be maintained to ensure the validity of collected data. 


Tags Office of Research
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Storage and Retention of Data
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Lunch and Learn with Omega Scientific
Enjoy lunch on us while you learn about Omega Scientific's products that support your research.
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Introduction to sIRBs
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FDA Research Involving Drugs and Devices
This course will review what research is subject to FDA oversight, highlight the differences between OHRP and FDA regulations, learn the responsibilities of sponsors, investigators, and the IRB when conducting and reviewing research involving drugs and devices, and examine the requirements for conducting research with a drug or biologic/medical device.
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Not Regulated, Secondary Use, and Umbrella Applications
This course will review the Not Regulated, Secondary Use, and Umbrella application types in eResearch and when these application types are applicable.
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OHRP’s Subparts B, C, and D -Special Populations
This course will examine the additional regulatory requirements for conducting research involving pregnant women, fetuses, neonates, children, and prisoners, including the requirements for these populations in a research project and obtaining informed consent.
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Federal and Institutional Requirements for Human Subject Research
This course will introduce the basics of conducting human subject research in compliance with federal regulations and institutional practices.
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Elements of Informed Consent
This course offers an overview of informed consent in human subject research. The course will examine IRBMED’s standard consent template and focus on how it reflects federal requirements.
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Introduction to eResearch
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Waivers, Alterations, and Alternative Forms of Informed Consent
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Dr. John Moran, University of Michigan
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Matthew Brody, Ph.D. - Pfizer Upjohn Early Career Research Professorship in Molecular Pharmacology Ceremony
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Matthew Brody headshot
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